Auxiliary data as surrogates for SCORE2 risk calculator inputs – design and methodology of the Frauenherzen study in apparently healthy women aged 40–69 years

BACKGROUND: Menopause is associated with increased risks for chronic non-communicable diseases, including cardiovascular disease (CVD), type 2 diabetes mellitus, cancer, osteoporosis, and dementia. Existing clinical prediction tools for calculating the individual CVD risk, such as the online risk calculator Systematic Coronary Risk Evaluation model version 2 (SCORE2) requires input parameters such as age, blood lipid levels (total cholesterol (CH), HDL-CH), systolic blood pressure (BP), and personal and family history of CVD. However, in many cases, these parameters may not be readily available. Therefore, this study aims to utilize data from wearable devices, including heart rate and daily step count, to reduce uncertainty about CVD risk in healthy women who lack BP and the two blood lipid values. These three input values of the SCORE2 typically require an in-person visit to the physician. METHODS: This paper describes the rationale and methodology of a monocentric, exploratory, cross-sectional observational study conducted at the University Hospital of Bern, Switzerland. Women aged 40-69 years with and without cardiovascular risk factors were invited to participate. The study involves two visits including blood sampling, clinical and psychometric assessments, and continuous recording with a Garmin® wearable device for seven days. In addition, validated questionnaires assess psychosocial health, stress, and quality of life. CONCLUSION: The Frauenherzen study provides a comprehensive design framework for evaluating cardiovascular health in middle-aged women using digital biomarkers. By describing the study design and methods in detail, we aim to enhance transparency, enable replication, and inform future research on sex-specific cardiovascular risk stratification and preventive strategies.